Device Classification Name |
protector, transducer, dialysis
|
510(k) Number |
K891752 |
Device Name |
DA-46 FLUID BARRIER |
Applicant |
AKCESS MEDICAL PRODUCTS, INC. |
789 JERSEY AVE. |
NEW BRUNSWICK,
NJ
08901
|
|
Applicant Contact |
EDWARD J HOPKINS |
Correspondent |
AKCESS MEDICAL PRODUCTS, INC. |
789 JERSEY AVE. |
NEW BRUNSWICK,
NJ
08901
|
|
Correspondent Contact |
EDWARD J HOPKINS |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 03/23/1989 |
Decision Date | 04/07/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|